NCT05595876

Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype

Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype, a Novel Approach in the Endovascular Treatment of Acute Ischemic Stroke: the STRIPE Randomized Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis. The ASTER Trial showed similar results between stent-retrievers and contact aspiration concerning the recanalization grade in anterior circulation occlusions. However, we still observe late and futile recanalizations, secondary either to extended ischemic lesions at baseline, long-time procedures or intraprocedural complications. The First Pass Effect that is the complete/nearly complete recanalization after the first maneuver, independently on the technique used, has been strongly associated with better clinical outcomes . In a recent paper we proposed a novel approach to identify those cases that could be treated with a specific technique (stent-retriever) with higher chances to achieve a complete or nearly complete recanalization, with lower procedure times and lower complication rates. This approach is focused on the identification of a regular or irregular phenotype of the occlusion site in patients with an M1-Middle Cerebral Artery occlusion. The phenotype is defined as "regular" whether the profile of the occlusion is abruptly cut without any irregularity and as "irregular" if any irregularity of the profile of the occlusion is observed. One of the hypotheses that could explain these results could be related to the composition of the clot : a soft and less organized clot could be more easily flattened by the pulsatile flow and therefore determine a regular aspect of the occlusion. A more solid and organized clot would, on the contrary, maintain an irregular profile because it would not be flattened by the blood flow and the contrast medium could highlight the irregularities of the proximal face of the clot. The latter could be a favorable target for the use of a stent-retriever since the interaction between a solid clot and the struts of the stent could increase the chance to retrieve the clot. Therefore, we propose this randomized controlled trial to assess the superiority of stent-retrievers compared to contact aspiration in the treatment of irregular phenotype occlusions of the M1-Middle Cerebral Artery.

Detailed description

Statistical analyses will be independently performed by the Biostatistics Department of University of Lille under the responsibility of Julien Labreuche. Data will be analyzed using the SAS software (SAS Institute Inc, Cary, NC, USA). A detailed statistical analysis plan will be written and finalized prior to the database lock. Baseline characteristics will be described for each group. Quantitative variables will be expressed as mean (standard deviation) or median (interquartile range) for non-Gaussian distribution. Qualitative variables will be expressed as frequencies and percentages. Normality of distribution will be assessed graphically and using the Shapiro-Wilk test. All applicable statistical tests will be 2-sided and no correction for multiple comparisons will be applied; all secondary objectives will be considered as exploratory and results were reported with only effect size estimates with their confidence intervals (CIs). All CIs presented will be 95%CI and 2-sided. The final report will be written, based on the CONSORT statement recommendations.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
PROCEDURE	stent retriever thrombectomy	The technique used should be in accordance with the device IFU (instructions for use). A large bore access guide catheter possible is mandatory. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE (european compliance)-marked stent retriever device is then deployed across the occlusion. A contact aspiration large bore catheter can be used in association with the stent retriever. A minimum of 3 attempts with Stent retriever should be performed. A revascularization score will be recorded after each device attempt.
PROCEDURE	contact aspiration thrombectomy	A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch microwire inside is then introduced into a large-bore aspiration catheter and this construct is introduced into the long sheath as a unit. A large bore balloon guide catheter has to be placed into the cervical internal carotid artery. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control angiogram may be used to document the extent of occlusion and thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. Once thrombus will be close to the aspiration catheter, then the system will carefully removed as a unit under continuous aspiration.

Timeline

• Start date: 2022-12-19
• Primary completion: 2025-02-01
• Completion: 2025-11-01
• First posted: 2022-10-27
• Last updated: 2024-02-29

Locations

9 sites across 1 country: France